一项针对南非青少年女孩和年轻女性的母子 HIV/性传播感染预防计划的个体化随机对照试验：IMARA-SA 研究方案。
An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol.
机构信息
Center for Dissemination and Implementation Science, Department of Medicine, University of Illinois at Chicago, 818 S. Wolcott, Chicago, IL, 60612, USA.
Desmond Tutu HIV Center, Cape Town, South Africa.
出版信息
BMC Public Health. 2021 Sep 20;21(1):1708. doi: 10.1186/s12889-021-11727-3.
BACKGROUND
South Africa has the world's largest HIV epidemic, but South African adolescent girls and young women (AGYW) acquire HIV at twice the rate of and seroconvert on average 5-7 years earlier than their male peers. Female caregivers (FC) are an untapped resource for HIV/STI prevention in South Africa and offer a novel opportunity to strengthen AGYW prevention efforts. This study will evaluate the effectiveness and cost-effectiveness of an evidence-based mother-daughter HIV/STI prevention program tested in the United States and adapted for South Africa, Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), to decrease STI incident infections and increase HIV testing and counseling (HTC) and PrEP uptake in AGYW.
METHODS
This is a 2-arm individually randomized controlled trial comparing IMARA to a family-based control program matched in time and intensity with 525 15-19-year-old Black South African AGYW and their FC-dyads in Cape Town's informal communities. AGYW will complete baseline, 6-, and 12-month assessments. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (total 10 h) that includes joint and separate mother and daughter activities. Primary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 6 months. Secondary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 12 months, sexual behavior (e.g., condom use, number of partners), HIV incidence, and ART/PrEP adherence and intervention cost-effectiveness. AGYW who test positive for a STI will receive free treatment at the study site. HIV positive participants will be referred to ART clinics.
DISCUSSION
Primary prevention remains the most viable strategy to stem new STI and HIV transmissions. HIV and STI disparities go beyond individual level factors, and prevention packages that include supportive relationships (e.g., FC) may produce greater reductions in HIV-risk, improve HTC and PrEP uptake, and increase linkage, retention, and adherence to care. Reducing new HIV and STI infections among South African AGYW is global public health priority.
TRIAL REGISTRATION
ClinicalTrials.gov Number NCT04758390 , accepted 02/16/2021.
背景
南非是世界上 HIV 疫情最严重的国家，但南非青少年女孩和年轻妇女（AGYW）感染 HIV 的速度是同龄男性的两倍，平均提前 5-7 年出现血清转换。女性照顾者（FC）是南非 HIV/性传播感染（STI）预防的未开发资源，为加强 AGYW 预防工作提供了新的机会。本研究将评估一种基于证据的母女 HIV/STI 预防方案的有效性和成本效益，该方案在美国进行了测试，并针对南非进行了调整，即知情、自觉、负责的青少年和成年人（IMARA），以减少 STI 感染，增加 HIV 检测和咨询（HTC）以及 AGYW 中 PrEP 的使用。
方法
这是一项 2 臂个体随机对照试验，将 IMARA 与基于家庭的对照方案进行比较，该方案在时间和强度上与开普敦非正规社区的 525 名 15-19 岁的黑人南非 AGYW 及其 FC 对子进行匹配。AGYW 将完成基线、6 个月和 12 个月的评估。随机分组后，AGYW-FC 对子将参加为期 2 天的小组研讨会（共 10 小时），包括联合和单独的母亲和女儿活动。主要结局是 6 个月时 AGYW 的 STI 发病率、HTC 使用率和 PrEP 使用率。次要结局是 12 个月时 AGYW 的 STI 发病率、HTC 使用率和 PrEP 使用率、性行为（例如，避孕套使用、性伴侣数量）、HIV 发病率以及 ART/PrEP 依从性和干预成本效益。检测出 STI 阳性的 AGYW 将在研究点获得免费治疗。HIV 阳性的参与者将被转介到 ART 诊所。
讨论
初级预防仍然是遏制新的 STI 和 HIV 传播的最可行策略。HIV 和 STI 差异不仅存在于个人层面，而且包括支持性关系（例如 FC）的预防方案可能会更大程度地降低 HIV 风险，提高 HTC 和 PrEP 的使用率，并增加联系、保留和坚持护理。减少南非 AGYW 中新的 HIV 和 STI 感染是全球公共卫生的重点。
试验注册
ClinicalTrials.gov 编号 NCT04758390，于 2021 年 2 月 16 日接受。
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